8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITAFLON PLUS/VASCULON
FDA 510(k)
FDA Class 2
·General Hospital
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MISTRAL-AIR PLUS (115V) BLOWER
FDA Adverse Event
Malfunction
·THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY·Product code DWJ·April 16, 2014
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 31, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 29, 2010
Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeable distal tip. The tip area consists of a radio-opaque gold-plated tungsten spring coil wound around a stainless-steel inner core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm. Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single. Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box. Material (UPN) H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX, FLEX C, Single/ Single. Material (UPN) H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX C TIP B5/5 per Box. Material (UPN) M001306020; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP, SINGLE/Single. Material (UPN) M001306021; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5 per Box.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DQX·April 19, 2010
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020